JP6864090B2 - Holder for acetabular cup implant - Google Patents

Description

Acetabular cup implants with large diameter bearing surfaces, such as surface reconstruction cups or large diameter total hip replacement (THR), are particularly difficult to hold during implantation. The surgeon must force the cup into a pre-treated, slightly smaller sized bone fossa during mating, ensuring that the cup is implanted in the correct orientation that is important for the function of the hip implant. It doesn't become. In addition, it is essential to protect the bearing surface from damage in this compulsory fitting process. The most customary THR cup consists of an outer shell and a separate bearing liner that is inserted after the metal shell has been implanted. Therefore, the interior of the metal shell is used to provide retaining features for introduction / fitting shafts such as threads or bionet attachments. However, this area cannot be used for surface reconstruction cups with pre-fitted liners because the inner surface forms a bearing surface. In addition, the lateral surface is usually completely embedded in the bone fossa, so only the rim of the cup is accessible. Previous surface reconstruction designs have attempted to solve this problem in various ways, but by reducing bearing arcs or lateral fixation surfaces, or by reducing the snugging and deterioration of soft tissue structures such as the lumbar tendon near the cup rim. The resulting retention feature has resulted in a design compromise. Manufacturers' attempts to provide appropriate cup retention measures are now recognized to have serious and detrimental effects on the clinical outcome of many surface reconstruction designs, partly because of these issues. Withdrawal from clinical use.

Non-metallic bearing materials utilized by large diameter THRs, including new generation surface reconstruction implants and zirconia reinforced alumina ceramics (ZTA) and crosslinked ultra high molecular weight polyethylene (UHMWPE), pose an even greater challenge for cup retention during implantation. .. In the case of ZTA, it is technically difficult and very expensive to add a small (if not desirable) retaining feature that is possible with metal due to restrictions on the manufacturing process and the hardness of the material. Also, in the case of UHMWPE, maintaining the total wall thickness is important for wear characteristics and material strength, so a holding feature portion that reduces the wall cross section is not desirable. In addition, some new generation devices are for uniquely rotationally aligning asymmetric features on the cup, which further makes cup holding difficult.

To overcome these difficulties, the present invention provides a cup holding measure that does not require a special holding feature on the cup and further protects the implant bearing surface during forced insertion.

This embodiment includes three elements: an inset device or introducer assembly (introducer), a cover assembly (cover), and a cup implant (cup). The fluid in the sealed cavity under low pressure establishes a holding grip force between the three elements. The sealing cavity is established by two seals and a check valve. One seal is made between the introducer and the cover and the other seal is made between the cover and the cup. A check valve is incorporated into the introducer to allow air and excess fluid to flow out of the sealed cavity when the three elements are compressed together (while preventing fluid or air re-entry into the cavity). To form.

The fluid used to fill the sealed cavity is preferably any liquid freely available in the operating room (eg, sterile water; variants of sterile water include Ringer's solution, saline, etc.). This may be ambient temperature, but is typically cooled. The fluid is introduced by injecting and filling the cup in an upright cup in the opened package or on a sterile surface. The cover is then inserted onto the cup and then the introducer is inserted into the cover. The excess fluid is provided by filling the cup so that the surface air is first pushed out of the cavity through the check valve and then the excess fluid is pushed out.

In one form, the low pressure of the fluid is obtained by the elastic features on the cover adjacent to the flange on the introducer attachment. The elastic feature bends down to reduce the volume of the sealing cavity. The elastic feature bends within its elastic limit and forcibly returns to its non-bent state in an attempt to hold the fluid at low pressure, thus maintaining low pressure. The low pressure state of the fluid pulls all three elements together to form a tight fit between the three elements, making the entire assembly feel rigid. The force applied between the introducer and the cup is automatically oriented to pass through the elastic feature by positioning on the cover adjacent to the introducer attachment. Elastic features are a way of converting mechanical forces into fluid attraction and can be obtained in a variety of alternative fashions with integral features on the cover or additional components such as bell-bills washers.

The elastic feature on the cover preferably comprises at least one fin or finger. Preferably, one or more light flexing fingers and stiffer flexing fingers are provided. Lightly bent fingers are lifted higher and therefore require only light force to first engage the introducer flange and push it down to the level of difficult to bend fingers. All bent fingers then work together and require greater force to reach the bottom and push down to a position in contact with the solid part of the cover.

In use, the elastic feature reduces the volume of the sealed cavity in both the light flexion stage (first stage) and the difficult flexion stage (second stage). The second step is to completely bottom out the elastic features. First, in the first stage, the holding force between the three elements is obtained by pushing the three elements together with a light hand force. This holding force is sufficient to place the cup in place in the patient's hip fossa. However, when the surgeon impacts the introducer with a hammer blow required to jam fit the cup into the hip fossa, the elastic feature enters the second stage (difficult to bend). This further reduces the volume of the sealed cavity and increases the stiffness of the elastic feature (the elastic feature is still within the elastic limit and attempts to return to the non-flexed state with considerable force), 3 The strength of retention between the two elements increases. When the elastic feature reaches the end of the stroke (when it reaches the bottom), it retains its position under the ferrofluidic seal. When the cap is fully bottomed out, it has the rigidity of the solid part, so the force of the hammer strike is transmitted more efficiently to push the cup in.

Have stronger holding force when the cup is fitted, as the cup may be out of alignment when the fit is increased, or the surgeon may want to adjust the alignment as the cup advances towards full seating. Is desirable. In addition, the force of the hammer strike is efficiently transmitted where it is needed, and the cover regains rigidity in the solid part so that the surgeon can feel and detect when the cup is fully seated (second stage). ) Is desirable.

Once the cup is completely inserted into the hip fossa, the low pressure fluid seal is released by manually opening the check valve.

Another technique that describes the mechanism for obtaining retention between the introducer, cover and cup is that the fluid continues to receive suction (rather than low pressure) in the sealed cavity. Therefore, the fluid suction force pulls all three elements together to form a tight fit between the three elements, making the entire assembly feel rigid. The suction force increases when the elastic feature portion bends from the first stage to the second stage, and the suction force is released by manually opening the check valve.

When the liquid exhibits both adhesive force (the tendency of the liquid to adhere to the surface on which the liquid is placed) and cohesive force (the tendency to resist separation in the liquid), FIGS. 1 to 4 and 10 to 10 described above. It is not essential to incorporate elastic features to reduce the volume of the cavity and to reduce the pressure in the liquid as shown in FIGS. 14, 17-24 and 27. Without such elastic features, if a sealed cavity for the liquid is maintained, the device by adhesive / cohesive forces in the liquid and by seals and valves that prevent air from entering the liquid cavity. The holding power between the various elements of is established. Such holding force can be utilized by having a maximum surface area between the holding elements and a maximum surface congruence with even small gaps between them. This is particularly applicable to cover assemblies and cup implants.

In this way, a cover assembly that interacts with the fitting device in a form that can accumulate on a cover with elastic features, or in place of a cover with elastic features (ie, no elastic features). Have. The fitting device comprises a proximal end, a shaft, and a distal region that interacts with at least one component of the cover assembly, the shaft and / or distal region of the fitting device being a cup, cover. Further provided is a mechanism for preventing the entry of additional fluid into the cavity created in the assembly and fitting device coupling.

The mechanism that prevents the entry of additional fluid into the cavity is preferably a releaseable check valve. This type of valve is hollow (when the valve is opened) to allow air and excess liquid to flow out during the pressing phase together and to release the cup after the cup implant has been accurately positioned in the body. Allows air to enter and reduce holding power. In addition, the maximum retention between all three elements is sometimes difficult to utilize because the available surface area to utilize the adhesion / cohesion is small and it is sometimes difficult to utilize the adhesion / cohesion retention between the introducer and the cover. Mechanical lock features can also be adopted to utilize the quantity.

Those skilled in the art will appreciate that it is desirable to operate this type of system with a liquid rather than air, as liquids are relatively incompressible compared to gases. This is the basic reason why hydraulic pressure is used as a source of mechanical force or control when high forces are required and pneumatics are used as a source of mechanical force or control when low forces are required. Also, since fluids are relatively incompressible under high pressures compared to gases, the opposite is true under low pressures (suction or tension), and liquids are relatively non-expandable compared to gases. Therefore, according to the present invention, it is desirable that much higher retention is possible when (sterilized) water is used and that all air (or as much air as possible) be removed from the sealed cavity. The air remaining in the cavity reduces its holding power and causes a "sponge-like" feel similar to that of air leaking into a hydraulic braking system in an automobile. The features of all three elements and the method of assembly thereof are designed to extrude all air and leave only sterile water in the sealed cavity.

However, although the holding power is typically not so large, it is a feature of the present invention that it also functions with air instead of liquid (for example, water). Therefore, the introduction of sterile water is not compulsory, but a matter of choice for the surgeon. However, this is less desirable as the benefits of maximum retention are multiple, but having a partial vacuum of air or low pressure of air or suction of air (rather than low pressure or suction of water). The function can be explained as being substantially the same as the above, except that the holding force is obtained by the above.

Preferably, the cover is disposable and consists of three parts made of a plastic material such as nylon and a seal made of a softer material such as silicone. However, in another embodiment, the cover comprises a single plastic part and an O-ring seal. The cover can be supplied with the implant or separately within the instrument set. Preferably, the introducer is disposable and consists of a long shaft made of a metal such as an aluminum alloy, peripheral parts forming a seal, a check valve and means for fixing them together. The metal shaft is for transmitting the force from a hammer strike outside the surgical site to force the cup into the patient's hip fossa.

The cup shown in the drawing below is a contoured surface reconstruction cup, but the present invention is of any type of hip bone made from one part or two parts pre-fitted with a bearing liner. Can be used for mortar cups. Those skilled in the art will appreciate that there are various types of hip cup implants for surface reconstruction and total hip replacement (THR). Surface reconstruction cup implants include monoblock cups made from ceramic, metal and plastic materials with circular (planar) rims or contouring rims. In addition to the options described above, THR cup implants include a metal outer shell with a ceramic, plastic or metal bearing insert with a circular (planar) rim or contoured rim. The functionality of the present invention relies solely on smooth bearing surfaces to create a seal that is common to all of the above options. Because all cup bearings must be very smooth and highly finished, their application extends to all hip cup implants.

In one embodiment of the present invention, there is provided a system comprising the following: That is,
(I) A medical device and a holding device that interacts with the medical device or with an insert located in or on the medical device and between the medical device and / or the insert and the holding device. Interaction creates a cavity within the coupling of the medical device and / or insert and the retainer, the cavity is at least partially filled with fluid, and the retainer is the medical device and / or insert. A cover assembly for placement within, said cover assembly,
A proximal surface, the proximal surface comprising a region in which the proximal surface can interact with or accept an inset device.
A distal surface that is located away from the proximal surface of the cover assembly and is arranged to fit into the medical device and / or insert, wherein the distal surface comprises at least a seal. ,
With medical equipment and holding devices,
(Ii) An fitting device, wherein the fitting device is
Proximal end and
With the shaft
A distal region that interacts with at least one component of the cover assembly.
With
With the fitting device, the shaft and / or distal region of the fitting device further comprises a mechanism for preventing the entry of additional fluid into the cavity.
To be equipped.

In one form, the mechanism that prevents the entry of additional fluid into the cavity can be a one-way valve. The one-way valve can be placed at any suitable point on the fitting device, eg, along the shaft of the fitting device and / or at the distal region / tip / end. The one-way valve typically fluidly communicates with the cavity and external environment of the medical implant / retention device. When the valve is placed on the shaft, there is a passage extending from the valve port (exit port) to and through the distal end of the shaft to connect the cavity to the valve. If the valve is located in the distal region of the shaft (eg, within the tip of the shaft and / or protruding from the tip of the shaft to interact with a hole or cavity in the cover assembly), a passage is provided within the shaft. It is preferable to be able to push out the fluid. However, the existence of a passage in such a form is not an indispensable requirement. Excess fluid in such cases can be pushed out by forcing the seal that the cover assembly creates between the implant / insert surface.

In one embodiment, the distal region of the fitting device comprises a pin, which can be actuated to releaseably seal the cavity. Cavity sealing can be obtained in various forms. Preferably, a portion of the pin has a profile that fits into a portion of the hole that extends through the cover assembly and has a complementary profile. Those skilled in the art will appreciate that there are many types of profiles that can achieve the desired effect. For example, the pin can have a pointed end with at least a partially conical profile. The holes in the cover assembly can have regions with complementary shapes that accept the pins to provide a sealed fit. Other forms can include pins with convex or spherical end profiles that fit into a concave or arched hole profile. Alternatively, the end of the pin may optionally have a cylindrical profile with an additional seal (such as an O-ring or the like).

The portion of the hole in the cover assembly that interacts with the pin can have a profile that varies throughout its length from the distal plane to the proximal plane. For example, the main part of the hole can have a cylindrical profile and only the proximal end can have a shape that accepts the sealing pin.

The diameter of the holes extending through the cover assembly can also vary. For example, in the distal region of the cover assembly, the holes can have a relatively small diameter. For example, a small diameter can change gradually (eg, with a tapered profile) or abruptly to become a hole with a wider diameter so that it is wide enough to accommodate the distal end of the inset device. ..

An additional seal can surround the passage of the cover assembly in a position where the passage is widened to accommodate the fitting device. The distal end of the fitting device can be seated on this seal when inserted into the cover assembly. The pin can extend from the distal end into the valve seat of the passage.

In some embodiments, the distal region of the fitting device further comprises a locking mechanism that interacts with the holding device to help maintain a secure connection between the fitting device and the holding device.

In some embodiments, the distal region of the fitting device comprises a pin, the pin can be actuated to release and seal the cavity, and the pin locks and unlocks the fitting device into the retaining device. Interact with the locking mechanism to allow or prevent the locking mechanism from interacting with the holding device, respectively.

In one form, a system comprising a medical device and a holding device that interacts with the medical device is provided. The interaction between the medical device and the holding device creates a cavity between the medical device and the holding device, which provides means to allow the cavity to be sealed. The system
a) Means for generating low pressure or suction in the cavity,
b) Means for maintaining the low pressure or suction force and
To be equipped.

The medical device is preferably a cup implant. In certain preferred forms, the implant is a hip implant. Implants of this type typically have a smooth concave surface that, upon use, interacts with the ball implant to create a bulbous joint. A smooth concave surface is useful in that it can form a seal with the holding device. Seals are important because they allow the generation of low pressure environments or suction forces within the cavity between the medical device (eg, cup implant) and the retention device.

As discussed in more detail below, there are numerous means for creating low pressure or suction in the cavity. One of these means is in the configuration of the holding device itself. It can comprise a cover assembly having an elastic and elastically deformable portion, which for example urges the cover assembly away from the implant (eg, the elastic portion is the concave surface of the implant). Bias the introducer device (fitting device) away from the cover assembly after the fitting device is connected to the cover assembly (if located distal to the abutting cover assembly) (eg, elastic). When the portion is located proximal to the cover assembly away from the concave surface of the implant and abuts the fitting device), it acts to generate low pressure or suction in the cavity.

In addition to or instead, the holding device may be equipped with a plunger mechanism. The plunger mechanism typically has fluid communication with the passageway coupled to the fitting device and fluid communication with the cavity formed between the cover assembly and the medical device (eg, implant). To be combined. By pulling the plunger back in this way, the fluid is "sucked" from the cavity towards the plunger mechanism and a seal is formed between the cover assembly and the implant so that low pressure or suction force is created in the cavity. Will be generated. One of ordinary skill in the art can predict many different forms. For example, the plunger can be equipped with a screw accessory coupled with a fitting device, which allows the liquid to be drawn to the plunger when the screw on the plunger is loosened and vice versa. Alternatively, a plunger form in which the plunger is pulled by using a lever coupled with the fitting device is possible. Alternatively, a syringe-like structure coupled with the fitting device is also possible, in which case the syringe-like structure also acts to aspirate the fluid from the cavity.

In another form
c) Means and means for reducing the cavity volume from its initial volume, wherein the initial volume is the volume of the cavity when the holding device is inserted into the medical device to a set position.
d) Means for maintaining the reduced cavity volume and
A system is provided that further comprises.

By the initial volume being the volume of the cavity when the retainer is inserted into the medical device to the installation position, the cover assembly of the retainer is of the medical device (cup implant) in the initial setup of the system. It will be placed inside. This is usually after the liquid has been applied to the implant. Therefore, in the initial insertion, there is a displacement of the fluid in the cup implant as the cover assembly moves into the space previously occupied by the fluid. When the cover assembly reaches the set position in the initial setup, it is considered to have set the "initial volume" of the cavity. The set position is, for example, the position when the cover assembly interacts with the rim of the medical device so that the body of the cover assembly is no longer pushed into the implant. Alternatively, the seal on the cover assembly may be in full contact with the wall of the implant. This typically occurs before the cover assembly is fully inserted into the implant. The cavity volume can then be manipulated and reduced in various ways as described herein.

Means for reducing the cavity volume from the initial volume are provided by elastic and elastically deformable portions on the cover assembly of the holding device. When located, for example, on the distal side of the cover assembly, this portion allows the cover assembly to be further pushed into the implant to further reduce the cavity volume after initial insertion. Similarly, if the elastic part is on the proximal surface of the cover assembly, when inserting the fitting device, the elastic part elastically deforms towards the distal end, further into the cavity. Allows insertion (including holes extending from the distal side to the proximal side through the cover assembly). The portion of the fitting device located in the through hole of the cover assembly therefore moves within the hole towards the distal end of the cover assembly, draining any fluid in the hole effectively. Reduce cavity volume.

Means for maintaining the reduced cavity volume are provided, for example, by sealing and the resulting suction effect, which prevents the array from returning to its initial relaxed position.

In a preferred embodiment of the system, the system further comprises a fluid, which is introduced into the system such that the fluid is in the sealed cavity. Preferably, the fluid is liquid and there is no or substantially no gas in the sealed cavity after the cover assembly has been inserted into the implant and excess liquid and gas have been removed. The advantage of a liquid over a gas is due to the relative incompressibility of the liquid. Preferably, the fluid is introduced before the cover assembly is placed into the implant. This can reduce the risk of gas being trapped in the cavity.

In some forms, kits are provided that include an implant, a cover assembly, an inset device, and a liquid container.

Preferably, the system also comprises means for releasing the low pressure or suction force of the fluid.

It can take the form of a valve coupled with an inset device, whereby when the valve is activated, the valve effectively breaks the seal between the cavity and the external environment and of the cavity. Balance the pressure inside. Such a valve is typically a one-way valve, such as a ball valve or O-ring, that allows fluid to flow out of the cavity but prevents gas or liquid from entering the cavity. Alternatively or additionally, the cover assembly can have a plug or valve coupled to the cover assembly, whereby the seal is broken through the cover assembly. In some embodiments, the cover assembly can have a pre-drilled hole extending from the distal region towards the proximal surface, and by perforating the proximal surface to reach the hole, the seal is broken. To.

In some forms, the system
Means for introducing the fluid into the cavity and / or for extruding excess gas and / or liquid may be further provided.

Preferably, the means for introducing the fluid is by injecting the fluid into the concave cup implant in advance. Fluid can flow from bottles, beakers, medicine bottles or syringes into the concave cup cavity. Full filling of the cup provides an excess amount of fluid, which pushes all air out of the cavity during assembly of the cover and introducer so that only the fluid remains in the sealed cavity. Helps you to. Excess liquid is extruded as the cover is assembled into the cup implant by spilling over the rim of the cup implant and / or through the holes in the cover. Additional excess gas and / or liquid is extruded through the check valve as the introducer is assembled into the cover.

In some preferred embodiments, the system comprises a holding device comprising a cover assembly for placement within a medical device, wherein the cover assembly comprises a cover assembly.
A proximal surface, the proximal surface comprising a region in which the proximal surface can interact with the fitting device.
A distal surface that is located away from the proximal surface of the cover assembly and is arranged to fit into the medical device, wherein the distal surface comprises at least one seal.
To be equipped.

In certain embodiments, it is not necessary to have an elastic portion that is coupled to the cover assembly in order to generate low pressure / suction force or act as a means to reduce cavity volume. For example, as discussed herein, low pressure or reduction in cavity volume can be produced by alternative means such as a plunger mechanism.

In another form, the cover assembly
At least one elastic and elastic deformation coupled to the cover assembly so that there is a natural bias in the elastic and elastically deformable region when elastically deformed in a stressed state and returns to its unstressed state. Possible area,
Further prepare.

As mentioned above, this is one form in which means for creating low pressure or attractive force in the cavity can be implemented. Similarly, this is one form in which means for reducing the cavity volume from the initial volume can also be implemented.

The elastic and elastically deformable region can be part of or combined with the proximal surface of the cover assembly. This form may be preferred when an inset device is used that fluidly communicates with the cavity between the cover assembly and the implant.

Alternatively or instead, the elastic and elastically deformable region can be part of or combined with the distal surface of the cover assembly. Such a form is preferable when the fitting device does not fluidly communicate with the cavity.

In some forms, the elastic and elastically deformable region is formed integrally with the cover assembly.

In some forms, the elastic and elastically deformable region is formed from a portion of the material that extends from the cover assembly. The material can be the same material as the material of the cover assembly, or it can be a different material from each side of the cover assembly. In some forms, it can be a mixture of the same and different materials as the material of the cover assembly.

In some forms, the portion of the material extending from the cover assembly comprises at least one finger or fin. It is typically made of one or more cuts of material between the fins, thereby producing fins of the material between the cuts.

Preferably, at least one fin comprises a plurality of fins, and one or more of the plurality of fins have substantially the same dimensions. Alternatively or additionally, at least one fin comprises a plurality of fins, and one or more of the plurality of fins has different dimensions.

In a preferred embodiment, it comprises a plurality of thin fingers / fins and a plurality of thick fingers. One or more fingers (preferably one or more thin fingers) interact with the inset (proximal surface) or cup implant (distal surface) before the thicker fingers abut. As such, it can optionally extend above the plane of one or more thicker fingers.

In addition to or instead, elastic and elastically deformable regions can include one or more springs, one or more washers (eg, bellville washers) or a combination of springs and washers.

In a preferred embodiment, the cover assembly is configured such that at least a portion of the elastic and elastically deformable region can reach the stopper before losing the elastic deformation when stressed. The stopper forms a platform, whereby the elastic and elastically deformable area can efficiently transmit force to the elastic and elastically deformable area and the entire body of the cover assembly. Effectively form a non-movable unit together with the three-dimensional body.

The stopper that forms the platform that the elastic and elastically deformable region abuts when stressed is that the part of the elastic and elastically deformable region that abuts the platform is urged to a non-stressed state by plastic deformation. Can be adequately separated from the elastic and elastically deformable region so that it abuts before it is lost.

As mentioned above, in some preferred embodiments, the cover assembly passes this from the proximal plane and through it to the distal plane, especially when an inset device with a passage for fluid communication with the cavity is used. It has a hole that extends through it.

As mentioned above, the cover assembly further comprises a hole beyond the seal on the distal surface, which extends into the cover assembly but does not penetrate the proximal surface. This hole is designed to be accessible from the proximal side of the cover assembly to break the seal between the cavity and the external environment (eg, by perforation or by a preformed removable plug).

In a particular form, the cover assembly may comprise a plurality of parts that fit together to form a cover assembly, wherein the plurality of parts may include.
A first component comprising at least the proximal surface and optionally the distal surface.
Optionally, with a second component comprising the distal surface,
With a sticker
Means for locking the seal to the first and / or second component, and
To be equipped.

In another form of the system, the system further comprises a fitting device, the fitting device comprising a component that interacts with at least one component of the cover assembly.

In some forms, the fitting device does not need to have a passage for fluid communication with the cavity. This is especially true in the form in which the cover assembly is configured for use in solid fitting devices.

However, preferably, the fitting device is
Proximal end and
With the shaft
The fitting device is a distal region that includes a passage, wherein the passage has an inlet port at the distal end / tip of the distal region and an exit port at a point on the shaft away from the distal end / tip. , Further provide means for blocking the removable exit port.

This form provides an example of means for generating a low pressure or suction force in the cavity and for maintaining the low pressure or suction force.

Preferably, the means for detachably blocking the outlet port is a check valve. This can optionally be, for example, a ball valve and / or an O-ring or the like.

As described above, in the form in which the inset device comprises a passage designed to fluidly communicate with the cavity between the cover assembly and the implant, the cover assembly of the holding device is from the proximal surface of the cover assembly. It comprises a hole that passes through and extends through it to the distal surface, at least a portion of the hole having dimensions to accommodate a portion of the fitting device.

The fitting device can include a flange in the distal region. The flange can interact with the holding device to stabilize the sitting of the fitting device on or within the holding device.

Again, as discussed herein, in some embodiments, the fitting device further comprises a mechanism for generating low pressure or suction in the cavity, such as by using a plunger that communicates with the cavity. .. The plunger is adjustable to pull or push fluid in the passage, and thus in the cavity.

In use, it is preferable to allow elastic deformation of the pressure towards the distal surface of at least a portion of the elastic and elastically deformable region of the cover assembly when appropriate pressure is applied to the fitting device. It is a form.

Preferably, the cover assembly can reach the stopper at least a portion of the elastic and elastically deformable region under pressure, which forms a platform thereby elastically and elastically deformable. Possible areas are elastic and elastically deformable areas and effectively form non-moving units with the body of the cover assembly so that force can be efficiently transmitted throughout the body of the cover assembly. Further elastic deformation of the elastic and elastically deformable region is prevented by the stopper.

Although a system comprising an implant, a retention device and an inset device has been described herein, the retention device and the inset device can be considered as separate entities that can be provided independently of the system, and the system is an innovation of the present invention. It should be found that the holding device and the fitting device can be modified to the extent that the desired form can be obtained.

In addition, the present specification presents a method of holding a medical device (implant) using a fluid, preferably a liquid. The fluid is introduced into the medical pin plant, the medical implant is then capped with a retainer, and the retainer drains excess fluid from the cavity formed between the medical implant and the cover assembly. The holding device is then operated to generate and maintain a suction force in the cavity, including a cover assembly arranged to form a seal.

Such an operation can further include reducing the cavity volume from its initial volume, said initial volume being the volume of the cavity when the holding device is inserted into the medical device to a set position. , Further can include maintaining the reduced cavity volume.

The holding device can include a cover assembly with elastic and elastically deformable regions. The operation of the cover assembly acts on at least a portion of the elastic and elastically deformable region to reduce the volume of the cavity, and the elastic and elastically deformable region then returns to a relaxed state. Prevents the pressure of the fluid in the cavity from decreasing.

The method is
(A) A step of introducing a fluid, preferably a liquid, into the cavity of the medical implant.
(B) The step of introducing the cover assembly of the holding device into the cavity of the medical implant, wherein the cover assembly drains excess fluid present in the cavity and said. The step, which forms the first seal between the cover assembly and the medical implant,
Can consist of.

The method is
(C) The step of introducing the fitting device into the cover assembly and
(D) A step of removing additional fluid from the cavity,
Can be further included.

The method can further include applying pressure to the fitting device to elastically deform at least a portion of the elastic and elastically deformable region of the cover assembly, the deformation being available for medical implants. Further reduction of the cavity space and further drainage of fluid from the cavity.

The method is
(E) A step of applying additional pressure to the fitting device so that the elastic and elastically deformable region abuts on the stopper of the cover assembly, wherein the stopper is elastic and elastically deformable. It forms a platform that prevents the region from plastically deforming and losing its bias to the unstressed state, and efficiently transfers force to the elastic and elastically deformable region and the entire body of the cover assembly. To be able to, step,
Including further.

Preferably, the method comprises the use of the system described herein.

The method can further include the step of creating a rupture of the seal between the medical implant and the retention device in order to release the retention device from the medical implant.

Next, examples of the present invention will be described with reference to the accompanying drawings.

It is an exploded view which shows all three elements, that is, the introducer assembly (introducer), the cover assembly (cover) and the cup implant (cup). It is a figure of the cover seen from above. It is sectional drawing of FIG. It is an exploded view of a holder. The entire introducer is shown. It is a partial view of the introducer in the state where the check valve is in the open position. It is sectional drawing of the partial introducer with a check valve in a closed position. It is an exploded view of a partial introducer. Shows where a cup placed on a flat surface is filled with sterile water from a bottle. It is an exploded view which shows the cup filled with water and the cover just before being inserted. It is a partial view of the introducer when the check valve is closed by hand. It is sectional drawing of the cover assembled in a cup just before the introducer is inserted. It is sectional drawing of the cover assembled in a cup with the introducer partially inserted. FIG. 5 is a cross-sectional view of the assembled device with the elastic features of the cover in the initial position and not pushed down. It is an enlarged cross-sectional view of the check valve opened by the passage of water flow. FIG. 5 is an enlarged cross-sectional view of a check valve closed to prevent water or air from returning to the internal cavity. FIG. 5 is a cross-sectional view of an assembled device in a state where the elastic feature portion of the cover is partially pushed down by the force of a hand (first stage). (Insert) FIG. 15 is shown repeatedly in FIGS. 17 and 18 to show that the check valve was opened by the passage of water. It is sectional drawing of the assembled apparatus in the state which the elastic characteristic part of a cover is completely pushed down by the fitting hammer force (second stage). FIG. 5 is a cross-sectional view of an assembled device in which the elastic feature of the cover is held in the fully depressed position (maximum holding force) by low pressure water in the internal cavity. Indicates a cup released after the check valve is manually opened. 21 to 24 show another embodiment of the cover. It is an exploded view of another cover. Shows another pre-assembled cover. It is sectional drawing of another cover which has been assembled. FIG. 25-28 are cross-sectional views of the introducer and another cover assembled with the cover (similar to FIG. 14 of the preferred cover above) FIGS. 25-28 show another embodiment of the introducer (1). The whole of another introducer is shown. It is a partial view of the introducer with the check valve in the closed position. It is sectional drawing of the introducer in the state which the check valve is in an open position. It is an enlarged view of FIG. 27. Shows the pre-assembled device as the cup implant is inserted into the patient's hip fossa (hammer not shown). 30-32 show three yet another embodiments of the introducer. It is sectional drawing of another introducer (2). It is sectional drawing of another introducer (3). It is sectional drawing of another introducer (4). 33-35 show yet another embodiment of the cover and introducer. It is an exploded view of three device elements (cup implant, cover and introducer). It is a cross-sectional view of three elements (the liquid is contained in the cup-in-plan). It is an exploded view of the introducer component. 36-44 show yet another embodiment of the cover and introducer. It is an exploded view of a cover component. It is sectional drawing of the assembled cover. It is an exploded view of another introducer. It is an exploded view of three device elements (cup implant, cover and introducer). FIG. 3 is a cross-sectional view of a cup implant and cover positioned together. FIG. 3 is a cross-sectional view of a cup implant and cover positioned perfectly together. FIG. 3 is a cross-sectional view of three elements assembled together, with the valve closed. FIG. 3 is a cross-sectional view of the three elements assembled together, with the valve open. It is sectional drawing of a partially disassembled introducer and a cover.

FIG. 1 shows all three elements: introducer assembly (introducer) 1, cover assembly (cover) 2 and cup implant (cup) 3. It can be seen from the figure that the contouring rim 5 of the cup matches the contouring flange 4 of the holder. However, in some embodiments, the rim and flange are flat instead of contoured, and the cup implant can consist of two or more parts. Further, the stopper 17 of the introducer 1 fits into the opening 9 of the holder 2 so that all three elements fit together during use.

2 to 4 show holders. Preferably, the holder is disposable. The holder can be assembled with the implant or supplied separately from the implant. As can be seen from FIGS. 3-4, this embodiment of the holder comprises four parts: a body 10, a seal 12, a washer 13 and a nut 14. When a nut is applied to the screw portion 11 of the main body 10 and tightened together, the seal is tightly sandwiched between the adjacent surfaces of the main body and the washer as shown in FIG. The body, washers and nuts are preferably made of plastic (such as nylon) that does not damage the hard implant bearing surface. Preferably, the holder is manufactured by an additive manufacturing process. Those skilled in the art will appreciate a variety of additional manufacturing processes, such as selective laser sintering (SLS) or stereolithography (SLA). Alternatively, these parts can be made of plastic, for example by injection molding or natural drying casting of resin. Alternatively, the part can be made of plastic by any other means, including machining. The seal 12 is a flat disc with a center hole and can be made from a soft material such as silicone that bends to the shape of the cup bearing surface to make a watertight / airtight seal. Alternatively, the seal can be made of nitrile rubber, thermoplastic elastomer (TPE) or polyurethane. Preferably, the seal is die cut from the sheet material.

The integral elastic feature on the cover body shown in FIGS. 2 and 3 consists of two lightly bent fingers 6 and four difficult to bend fingers 7. The lightly bent finger lifts higher and therefore engages with the introducer flange 19 first. Further, as shown in FIG. 3, the bent fingers 6 and 7 reach the solid portion 8 of the cover body during use.

5 to 8 show an introducer having an integrated check valve 16. As can be seen from FIGS. 7 and 8, this embodiment of the introducer is derived from seven components: a shaft 15, two O-ring seals 20, a valve body 21, a valve ball 23, a headed screw 22 and a set screw 25. Become. The two identical O-ring seals 20 and the valve body 21 are made of a soft material such as silicone and make the seals according to the shape of the mating surfaces. Alternatively, it can be manufactured from other soft materials such as nitrile rubber, thermoplastic elastomer (TPE) or polyurethane. The valve body 21 is preferably manufactured of plastic (nylon or the like) by an additional manufacturing process. The two screws 22 and 25 are standard parts made of metal or plastic.

The check valve 16 pushes the valve from the closed position where the valve body is in line with the shaft axis (as shown in FIG. 7) to the open position where the valve body rotates around the center headed screw (FIGS. 5 and 6). It can be opened and closed manually by rotating. In the closed position, the ball valve closes the hole 24 and the hole 18 connected to the hole 26 having an opening at the end of the shaft. The secondary opening is permanently closed by the set screw 25 and is present only to aid in the production of interconnected holes. The plastic valve body 21 is flexible enough to allow the ball 23 to be pushed away from the hole 18 by pressurized air or water flowing through the hole. However, when air or water is not under pressure or under low pressure, the ball valve 23 is urged to close and seals the hole 18. Those familiar with fluid control and / or pneumatics will find that there are a variety of check valve designs and standard products. A variety of forms can be used to establish the function of the check valve required separately from the embodiments shown herein, including the use of standard (off-the-shelf) check valves. The protruding feature 28 at the opposite end of the valve body fits into the recess 27 of the shaft 15 to hold the valve in the closed position and prevent accidental opening unless required to be opened by hand. .. The flexibility property of the plastic valve body allows the protrusion 28 to climb out of the recess 27 when turned to the open position by hand.

The function at the time of use will be described with reference to FIGS. 9 to 20.

The cup implant 3 is removed from the sterile packaging and placed on a flat surface 30. Then, as shown in FIG. 9, sterilized water 29 is filled.

The cover 2 is inserted into the cup 3 with the contours 4 and 5 (if present) substantially aligned as shown in FIG. 10, with the cup laid flat to avoid overflow.

The introducer is prepared by manually closing the check valve in the direction of the arrow as shown in FIG. The valve body 21 must be in line with the introducer shaft 15.

Next, as shown in FIGS. 12 and 13, the introducer is inserted into the cover with the cup and cover placed on a flat surface to avoid overflow (the introducer plug 17 opens the cover opening 9). Inserted into). FIG. 13 shows that when the seals (the cover seal 12 between the cup and the introducer seal 20 between the covers) are engaged, excess water is pushed out of the sealed cavity through the check valve 16. Shown. However, water and air are prevented from returning to the cavity because the valve automatically closes as shown in FIG. To emphasize this point, FIG. 15 is an enlarged view of FIG. 13 in which the ball valve 23 is opened by the outflowing water, and FIG. 16 is an enlarged view of FIG. 13 in which the ball valve is closed to seal the cavity. It is an enlarged view of the state.

For clarity, the flange 19 of the introducer rests on the lightly bent finger 6 of the cover without bending, as only sufficient force is used to insert the introducer in FIG. .. From FIG. 14 to FIG. 17, the process by which the lightly bent finger 6 bends downward (step 1) is shown, but in reality this will occur at the same time as the introducer is inserted. Further downward bending of the lightly bent finger reduces the volume of the enclosed cavity slightly, pushing some more water out of the check valve, as shown in the magnified view of FIG. The lightly bent finger 6 remains within its elastic limit and attempts to return to its non-flexed state, thereby holding the fluid at low pressure and keeping the finger in a downwardly bent position, thus maintaining low pressure. .. The low pressure state of the fluid pulls all three elements together by the holding force between the three elements. This holding force is sufficient to fit the cup in place in the patient's hip fossa.

FIG. 18 shows the process from the light flexion stage (first stage) to the difficult flexion stage (second stage) after the surgeon has fitted the fully assembled device to fit the cup implant into the hip socket. This fitting input is much larger and is sufficient to bend the difficult bending finger 7 and the light bending finger 6 downward to their lowest reach position. When all fingers are completely bent downwards, the volume of the enclosed cavity is reduced slightly again, pushing some more water out of the check valve 16 as shown in the magnified view of FIG. Since the flexed fingers 6 and 7 are still within the elastic limit, they try to return to the non-flexible state with considerable force, thereby keeping the fluid at a lower pressure and completely all the fingers as shown in FIG. It is kept in a downwardly bent position, so even lower pressure is maintained. The low pressure state of the fluid pulls all three elements together with a stronger holding force between the three elements. It is desirable to have greater holding power when the cup is fitted, as the surgeon may want to adjust the alignment until the cup is out of alignment or the cup is fully seated as the press fit progresses. In addition, the cover regains rigidity in the solid part so that the force is efficiently transmitted where the hammer force is needed and the surgeon can "feel" and detect when the cup is fully seated. That (second stage) is desirable.

FIG. 29 shows the pre-assembled device 39 as the cup implant is inserted into the patient's hip fossa, but does not show the hammer used by the surgeon to hit the shaft and snap the cup implant in place.

FIG. 20 shows a place where the grasping force is released by opening the check valve 16 by hand, removing the cover of the small hole 18 of the shaft, allowing air to enter and normalizing the low pressure, and breaking the seal. Is shown. The cover is separated with the introducer by a frictional fit between the O-ring of the shaft stopper 20 and the opening 9 of the cover.

Another embodiment of the cover 31 is shown in FIGS. 21-24. In this embodiment, the seal between the cover 31 and the cup implant is made by a large O-ring 32 housed in the groove 32 of the cover 31. Preferably, the O-ring groove follows the contour, but may instead be circular with no corrugations. In this embodiment, the cover comprises two parts, namely the cover body 31 and the O-ring 32. This embodiment has slightly different forms of the light bending finger 33 and the difficult bending finger 34. The function is the same as described above. Preferably, the body is made of a plastic (such as nylon) that does not damage the implant bearing surface. O-rings are made from a soft material such as silicone that creates a seal between the O-ring and the bearing surface of the cup to match its shape. Alternatively, it can be manufactured from other soft materials such as nitrile rubber, thermoplastic elastomer (TPE) or polyurethane.

Another embodiment of the introducer is shown in FIGS. 25-28. In this form, the check valve 36 is formed by an O-ring 38 that covers a small hole. The O-ring is subject to slight tension to seal the hole, except when pushed away by pressurized air or water flowing through the hole 40. However, when air or water is under pressure or under low pressure, the O-ring 38 seals the hole 40. This type of check valve can be opened by hand by pushing the lever 37 captured by the O-ring 38. When pressed, the lever swings on the fulcrum, pulling the O-ring away from the hole 40 by the action of a lever, as shown in FIGS. 27 and 28.

Another embodiment of the introducer is shown in FIG. Includes the same check valve 16 that can be manually released as seen in the previous embodiment. However, it includes the screw plunger 43, whose role is to further reduce the fluid pressure in the sealed cavity. The screw plunger consists of a screw 42 having an O-ring seal 41. The screw has a male thread that meshes with the female thread of the introducer body 40. When assembled with the cup implant and cover, when the screw is turned in the direction of arrow 44, the plunger is pulled back and a seal is created between the plunger and the hole, so this action further applies fluid pressure. Reduce to enhance grip between cup implants, covers and introducers. This additional screw plunger can act in parallel with or replace the elastic features of the cover.

Another embodiment of the introducer is shown in FIG. This includes the same check valve 16 that can be opened by hand as seen in the previous embodiment. However, as in the embodiment of FIG. 30, the plunger 49 is included and its role is to further reduce the fluid pressure in the sealed cavity. In this embodiment, the plunger is pulled out by the lever 46. The lever toggles around the pivot pin and is held in the pull-out position by the latch feature 47 of the cover that engages with the corresponding latch 45 of the body of the introduction. The lever 46 has the property of an elastic leaf spring so that it bends and hangs in a latching manner and continues to urge the plunger to a further pull-out position when caught. This additional lever plunger can act in parallel with or replace the elastic features of the cover.

Another embodiment of the introducer is shown in FIG. In this embodiment, a self-contained plunger assembly is attached distal to the introducer shaft and connected by a rigid tube 63 to the sealing cavity between the cup implant, cover and introducer. Rigid tubes include screw connectors 62 and 64 that connect the tubes to the plunger assembly and introducer body, respectively. The plunger assembly includes a main body 58, a plunger 55, an O-ring seal 61, a ball valve 60, a light spring 59, a screw collar 56 and a strong spring 57. The role of the plunger is to further reduce the fluid pressure in the closed cavity. The plunger assembly is actuated by tightening the screw collar 56 to compress the strong spring 57 and urge the plunger 55 to the drawer position. This additional plunger assembly can act in parallel with or replace the elastic features of the cover.

Another form is shown in FIGS. 33-35. In this embodiment, another cover 65, shown in FIGS. 33 and 32, comprises three parts, namely a body 66, a collar 67 and a seal 68. Preferably, the cover is disposable. When assembled together, the seals are snugly sandwiched between the body 66 and the collar 67, which are pressed together through a tight fit or screwed together by threads. The body and collar are preferably made of plastic (such as nylon) by selective laser sintering (SLS) or injection molding. In this form, there is no elastically deformable feature of the cover as described above. The seal 68 can be a flat circular disc with a central hole and can be made from a soft material such as silicone that bends to shape the cup implant bearing surface to form a watertight / airtight seal. Alternatively, the seal can be made of nitrile rubber, thermoplastic elastomer (TPE) or polyurethane. Preferably, the seal is die-cut from the sheet material.

33, 34 and 35 show the components of the check valve assembly 69, namely the valve body 70, the valve ball 71, the compression spring 72 and any preferred fixing means (eg headed screw) 73. Upon receiving the pressure of the compression spring, the valve ball closes the hole 74 of the introducer and combines with the other two seals 68 and the O-ring 75 to surround the liquid sealing cavity described above. We will discuss compression springs, but you should find that other technically known urging means can be used. In this embodiment, the valve is opened by operating the sliding portion 76 of the valve body 70 by pressing the button 77. This sliding portion pushes the valve ball 71 to shift the ball and temporarily open the hole 74 of the introducer. When the button is released, the valve automatically closes again. The function of this other embodiment is as described above, except that the retention force between the three elements depends on the adhesion / cohesion force of the liquid and the seal that prevents air from entering the cavity. is there. In this case, the pressure reduction provided by the elastically deformable features of the cover shown in FIGS. 1-4, 10-14, 17-24 and 27 is not provided.

Another form is shown in FIGS. 36-44. In this embodiment, another cover 78 shown in FIGS. 36 and 37 includes three components, namely a body 79, a collar 80 and a seal 81. Preferably, the cover is disposable. When assembled together, the seal is snugly sandwiched between the body 79 and the collar 80, which are optionally pressed together by several snap-fitting pegs 82, preferably four snap-fitting pegs. The collar 80 preferably has a small through hole 83 ending in a conical 84 adjacent to the larger central hole 85 of the cover body 79. The body and collar are preferably made of plastic (nylon ad), preferably by selective laser sintering (SLS) or by injection molding. In this form, as in the forms of FIGS. 33 to 35, there is no elastically deformable feature portion of the cover. The seal 81 can be a flat circular disc with an array of holes corresponding to the snap-fitting peg 82 and is a soft material such as silicone that bends to fit the bearing surface of the cup implant to create a watertight / airtight seal. Can be manufactured from. Alternatively, the seal can be made of nitrile rubber, thermoplastic elastomer (TPE) or polyurethane. Preferably, the seal is die cut from the sheet material.

38 and 39 show the introducer body 86, which is a component of the check valve assembly 87, namely a valve pin 88, a compression spring 89, a lock button 90, a release slider 91 and any preferred fixing means (eg headed). Screw) 92 is specified. The valve pins can be made of any suitable material, but are preferably made of stainless steel, optionally with a very good mechanical or polished finish. The finish should be one that provides a smooth surface that allows the pins of the aisle to provide a proper seal. The release slider 91 and lock button 90 are preferably made of plastic (such as nylon), preferably by selective laser sintering (SLS) or by injection molding. The release slider optionally incorporates an integral leaf spring 93 to urge the slider to a forward position (close the valve).

From FIG. 42, it can be seen that the pointed end 95 of the valve pin 88 blocks the conical opening 84 leading to the hole 83 of the collar 80 under pressure from the spring 89. We will discuss springs, but you will find that other technically known urging means can be used. This provides the function of a check valve. Further, the yoke portion 97 of the release slider 91 engages with the groove 96 of the valve pin 88 to act to move the valve pin (release the check valve) against the pressure of the spring 9. I understand.

The end of the valve pin was described as "pointed" and the opening 84 was described as "conical", but the concept behind the pin and the opening is that the pin blocks the opening and allows fluid to enter. It is said that an appropriate sealing force can be provided between the pin and the opening so as to substantially prevent it. Therefore, the exact shape of the pin and opening profiles is not important in this regard. What is important is that the profiles are complementary for proper sealing. Thus, in this regard, the profile can be, for example, (respectively) convex / concave or other complementary form.

The function at the time of use will be described with reference to FIGS. 40 to 44.

The cup implant 3 is removed from the sterile package and placed on a flat surface. The cup implant is then filled with sterile water as described above. The cover 78 is inserted into the cup implant 3 as shown in FIG. Then, as shown in FIG. 42, the introducer 94 is inserted into the cover. Air and excess gas are pushed out through the check valve 87, which automatically closes under pressure from the compression spring 89 to prevent water and air from returning to the cavity. The holding force between the cup implant and the cover is established by the cohesive / cohesive force of the liquid and by the seals and valves that prevent air from entering the fluid cavity. Further, in some preferred embodiments, a mechanical lock is established between the introducer and the cover by locking means, eg, the lock button 90. With all three elements held together, the cup implant can be positioned and forced into a pre-prepared hip fossa (as shown in FIG. 29).

From FIG. 43, it can be seen that the first small movement of the release slider pushes up the valve pin 88 and pulls the pointed end 95 from the valve seat 84 of the cover to open the valve. When the valve is opened, air can enter the cavity, as indicated by the small arrow in FIG. 43, which acts to release the hold between the cup implant and the cover. At this stage, if the introducer is equipped with a locking mechanism, the cover remains locked to the introducer by the lock button 90. However, as shown in FIG. 44, when the release slider 91 is further moved upward, the groove of the valve pin 88 moves together with the lock button 90 and is moved aside so that the cover 78 can be released from the introducer. Then, remove the cover from the introducer.

The cover assembly may further comprise an undercut area in a passage extending from the distal end to the proximal end, the undercut area being located towards the proximal end of the cover assembly. The locking mechanism and undercut region preferably contain complementary profiles. The undercut region preferably has smooth sides to prevent snagging of the locking mechanism and allow the locking button to engage and disengage smoothly.

Further provided are methods that include the use of the systems described herein.

Furthermore, it is assumed that any of the arguments of the various components of the system (or the system itself) with respect to a particular form are equally applicable to the components used in the other forms discussed herein. Thus, when a detailed argument of a particular component follows a more general argument of the form of the system, then the detailed argument of a particular component is in this form, even if it is not discussed in detail with respect to another form. Is also applicable.

In the field of cup implants, for example, to improve grip on the implant (inserts are typically arranged to be anchored to complementary features on the inner surface of the implant) or to one or more surfaces of the implant. It should be found that it is customary to use inserts with cup implants to provide protection to reduce the likelihood of damage to the implant. Thus, one of ordinary skill in the art will appreciate that references to implants discussed herein optionally include references to inserts attached to the implant.

Some preferred embodiments of the present invention will be described in E1 to E40.

E1. A system comprising a medical device and a holding device that interacts with the medical device, wherein the interaction between the medical device and the holding device creates a cavity between the medical device and the holding device. The system comprises means for the holding device to be able to seal the cavity.
a) Means for generating low pressure or suction force in the voids,
b) Means for maintaining the low pressure or suction force and
The system.

E2. The system according to E1, wherein the system is
c) Means and means for reducing the cavity volume from its initial volume, wherein the initial volume is the volume of the cavity when the holding device is inserted into the medical device to a set position.
d) Means for maintaining the reduced cavity volume and
A system that further prepares.

E3. The system according to E1 or E2, wherein the system further comprises a fluid, the fluid is introduced into the system such that the fluid is in the sealed cavity, preferably the fluid is a liquid. A system in which there is no or substantially no gas in the sealed cavity.

E4. A system according to any one of E1 to E3, wherein the system further comprises means for releasing the low pressure or suction force of the fluid.

E5. A system according to any one of E1 to E4, wherein the system is
Means for introducing fluid into the cavity and / or for extruding excess gas and / or liquid,
A system that further prepares.

E6. The holding device comprises a cover assembly for placement within the medical device, the cover assembly.
A proximal surface, the proximal surface comprising a region in which the proximal surface can interact with the fitting device.
A distal surface that is located away from the proximal surface of the cover assembly and is arranged to fit into the medical device, wherein the distal surface comprises at least one seal.
The system according to any one of E1 to E5.

E7. The cover assembly
At least one elastic and elastically deformable coupled with the cover assembly so that there is a natural bias in the elastic and elastically deformable region to return to the non-stressed state when elastically deformed in the stressed state. region,
The system according to E6, further comprising.

E8. The system according to E7, wherein the elastic and elastically deformable region is a part of or is attached to the proximal surface of the cover assembly.

E9. The system according to E7 or E8, wherein the elastic and elastically deformable region is a part of or is attached to the distal surface of the cover assembly.

E10. The system according to any of E7 to E9, wherein an elastic and elastically deformable region is formed integrally with the cover assembly.

E11. The system according to any of E7 to E10, wherein the elastic and elastically deformable region is formed from a portion of the material extending from the cover assembly.

E12. The system according to E11, wherein said portion of the material extending from the cover assembly comprises a material that is different from the respective faces of the cover assembly.

E13. The system according to E11, wherein the material portion is an extension of the material forming each surface of the cover assembly.

E14. The system according to any of E11 to E13, wherein the portion of the material extending from the cover assembly comprises at least one fin.

E15. The system according to E14, wherein at least one fin comprises a plurality of fins, and one or more of the plurality of fins have substantially the same dimensions.

E16. The system according to E14 or E15, wherein at least one fin comprises a plurality of fins, and one or more of the plurality of fins have different dimensions.

E17. The system according to any of E7 to E16, wherein the elastic and elastically deformable region comprises one or more springs, one or more washers (eg, Belleville washers) or a combination of springs and washers.

E18. The cover assembly is configured so that at least a portion of the elastic and elastically deformable area can reach the stopper before losing its elastic deformation when stressed, the stopper forming a platform, thereby elastic. The elastic and elastically deformable area works together with the body of the cover assembly for the non-moving unit so that the force is efficiently transmitted throughout the body of the cover assembly The system according to any one of E7 to E17.

E19. The stopper that forms the platform that the elastic and elastically deformable parts come into contact with when stressed, and the elastic and elastically deformable regions that come into contact with the platform are plastically deformed and put into a non-stressed state. The system according to E18, wherein the elastic and elastically deformable region is appropriately separated from the elastic and elastically deformable region so as to contact the platform before causing a loss of force.

E20. The system according to any of E6 to E19, wherein the cover assembly comprises a hole that extends from the proximal surface through it and through it to the distal surface.

E21. The system according to any of E6 to E20, wherein the cover assembly further comprises a hole beyond the seal on the distal surface, the hole extending into the cover assembly but not penetrating the proximal surface.

E22. The cover assembly comprises a plurality of parts that are fitted together to form a cover assembly, and the plurality of parts
A first component that includes at least the proximal surface and optionally also the distal surface.
Optionally, with a second component that includes the distal surface,
With a sticker
Means for locking the seal to the first and / or second component, and
The system according to any one of E6 to E21.

E23. The system according to any one of E1 to E22, further comprising a fitting device, wherein the fitting device comprises a component that interacts with at least one component of the cover assembly.

E24. The fitting device
Proximal end and
With the shaft
A distal region that includes a passage, wherein the passage comprises an inlet port at the distal end / tip of the distal region and an exit port at a point on the shaft away from the distal end / tip. Distal region and
With
The system according to E23, wherein the fitting device further comprises means for detachably blocking the exit port.

E25. The system according to E24, wherein the means for detachably blocking the outlet port is a check valve.

E26. The system according to E25, wherein the check valve is a hole valve and / or an O-ring or the like.

E27. The holding device comprises a cover assembly comprising a hole extending from the proximal surface of the cover assembly through it and extending through it to the distal surface, at least a portion of the hole providing a portion of the fitting device. The system according to any of E23 to E26, which has a size to accept.

E28. 28. E23-E27, wherein the fitting device comprises a flange in the distal region, and the flange can interact with the holding device to stabilize the seating of the fitting device on or in the holding device. system.

E29. The fitting device further comprises a mechanism for generating a low pressure or suction force in the cavity, such as by using a plunger in contact with the passage, the plunger pulling or pushing fluid in the passage and thus in the cavity. The system according to any of E24 to E28, which is adjustable for.

E30. Appropriate pressure applied to the fitting device is dependent on any of E7 to E19, E23 to allow elastic deformation of at least a portion of the elastic and elastically deformable region towards the distal surface of the cover assembly. The system according to any of E29.

E31. The cover assembly is configured so that at least a portion of the elastic and elastically deformable area can reach the stopper when stressed, and the stopper forms a platform, thereby being elastic and elastically deformable. Elastic and elastically deformable regions together with the body of the cover assembly effectively form a non-moving unit and are elastic so that the force is efficiently transmitted throughout the body of the cover assembly. The system according to E30, wherein the stopper prevents further elastic deformation of the portion of the target and elastically deformable region.

E32. Fluid A method of holding a medical device that uses a liquid, in which the fluid is introduced into the medical implant, the medical implant is then capped with a holding device, and the holding device is the medical implant and cover assembly. It comprises a cover assembly formed to drain excess fluid from the cavity formed between and to form a seal, and the holding device then generates a suction force in the cavity and the suction force. A method that is manipulated to maintain.

E33. The operation is to reduce the cavity volume from its initial volume, which is the volume of the cavity when the holding device is inserted into the medical device to a set position. The method according to E32, further comprising maintaining the reduced cavity volume.

E34. The holding device comprises an elastic and elastically deformable region, and the operation of the cover assembly acts on at least a part of the elastic and elastically deformable region in order to reduce the cavity volume, and is elastic. The method according to E32 or E33, wherein the elastically deformable region is then prevented from returning to a relaxed state and causing a decrease in the pressure of the fluid in the cavity.

E35. The above method
(A) Fluid A step of introducing a fluid, preferably a liquid, into the cavity of the medical implant.
(B) A step of introducing the cover assembly of the holding device into the cavity of the medical implant, the cover assembly draining excess fluid present in the cavity to cover the cover. A step that forms a first seal between the assembly and the medical implant,
The method according to any one of E32 to E34, which comprises.

E36.
(C) The step of introducing the fitting device into the cover assembly and
(D) A step of further removing the fluid from the cavity,
The method according to E35, further comprising.

E37. Further including the step of applying pressure to the fitting device to elastically deform at least a part of the elastic and elastically deformable region of the cover assembly, the deformation further expands the available cavity space of the medical implant. E34. The method of E34, which reduces and drains more fluid from the cavity.

E38.
(C) A step of applying additional pressure to the fitting device so that the elastic and elastically deformable region abuts on the stopper of the cover assembly, wherein the stopper is elastic and elastically deformable. It forms a platform that prevents the region from plastically deforming and causing loss of bias to the unstressed state, and efficiently transfers force to the elastic and elastically deformable region and the entire body of the cover assembly. To be able to, step,
The method according to E37, further comprising.

E39. The method according to any of E32 to E38, wherein the method comprises the use of any of the systems E1 to E31.

E40. The method according to any of E32 to E39, wherein the method further comprises the step of generating a rupture of the seal between the medical implant and the retention device in order to release the retention device from the medical implant.

E41. (I) A medical device and a holding device that interacts with the medical device or with an insert located above / in the medical device and between the medical device and / or the insert and the holding device. The interaction creates a cavity between the medical device and / or the insert and the holding device, the holding device comprises means for allowing the cavity to be sealed, and the holding device provides the medical device and / or the holding device. / Or a cover assembly for placement in the insert, said cover assembly.
A proximal surface, the proximal surface comprising a region in which the proximal surface can interact with or receive an inset device.
A distal surface located away from the proximal surface of the cover assembly and arranged to fit into the medical device and / or insert, wherein the distal surface comprises at least one seal. Face and
With medical equipment and holding devices,
(Ii) An fitting device, wherein the fitting device is
Proximal end and
With the shaft
A distal region that interacts with at least one component of the cover assembly, wherein the distal region comprises a passage, the passage in the distal portion of the distal region with an inlet port and from the distal portion. Distal region, comprising an exit port at a point on a distant shaft, wherein the fitting device comprises means for removably blocking the exit port.
Further equipped with an inset device and
With
The form of the medical device and / or insert, the holding device and the fitting device
a) Means for generating low pressure or suction in the cavity and / or b) Means for maintaining said low pressure or suction,
Form,
system.

Claims (34)

(I) A cup implant and a holding device that interacts with the cup implant or with an insert located above / in the cup implant, the cup implant and / or the insert and the holding device. The interaction between them creates a cavity with an initial volume in the resulting bond between the cup implant and / or the insert and the retainer, the cavity being at least partially filled with liquid and the retainer. The cover assembly comprises a cover assembly for placement within the cup implant and / or insert.
A proximal surface, the proximal surface comprising a region in which the proximal surface can interact with or receive an inset device.
A distal surface located away from the proximal surface of the cover assembly and arranged to fit into the cup implant and / or insert, wherein the distal surface comprises at least one seal. Distal surface and
With
The initial volume of the cavity is the volume of the cavity when the holding device is inserted into a set position within the cup implant, where the cover assembly interacts with the rim of the cup implant. To do
With cup implants and holding devices,
(Ii) An fitting device, wherein the fitting device is
Proximal end and
With the shaft
A distal region that interacts with at least one component of the cover assembly.
With
With the fitting device, the shaft and / or distal region of the fitting device further comprises a mechanism for preventing the entry of additional fluid into the cavity.
With
The cover assembly interacts with the rim of the cup implant when the cover assembly is placed within the cup implant and / or insert, and during insertion of the cup implant into the patient's joint. , A system configured to maintain the interaction of the cup implant with the rim. The holding device comprises a cover assembly comprising a first hole extending from the proximal surface of the cover assembly through it and extending through it to a distal surface, at least a portion of the first hole. The system according to claim 1, wherein the device has a dimension for accepting a part of the fitting device. The fitting device comprises a passage, the passage comprising an inlet port at a distal portion of the distal region and an outlet port at a point on the shaft away from the distal portion. The system of claim 2, further comprising means for detachably blocking the exit port. The system of claim 3, wherein the means for detachably blocking the outlet port is a check valve. The system of claim 4, wherein the check valve is a ball valve and / or an O-ring or the like. The system according to any one of claims 2 to 5, wherein the distal region of the fitting device comprises a pin, and the pin can be actuated to releaseably seal the cavity. The system of claim 6, wherein a portion of the pin has a profile that fits into a portion of the complementary profile of the first hole that extends through the cover assembly. Claims 1-7, wherein the distal region of the fitting device further comprises a locking mechanism that interacts with the holding device to help maintain a secure connection between the fitting device and the holding device. The system described in any one paragraph. The distal region of the fitting device comprises a pin, the pin is operable to release the cavity, and the pin is such that the locking mechanism locks the fitting device to a holding device. The system according to claim 8, wherein the system interacts with the locking mechanism to allow or prevent each interacting with the holding device to unlock. The form of the cup implant and / or insert, the holding device and the fitting device
a) Means for generating low pressure or suction in the cavity, and b) Means for maintaining the low pressure or suction.
The system according to any one of claims 1 to 9, wherein the system is formed. Claims 1 to which the fitting device comprises a flange in the distal region and the flange can interact with the holding device to stabilize the seating of the fitting device on or in the holding device. The system according to any one of 10. The fitting device further comprises a mechanism for generating a low pressure or suction force in the cavity by using a plunger in contact with the passage, the plunger pulling or pushing liquid in the passage and in the cavity. The system according to claim 3, which is adjustable for. Said system further comprises a liquid, said liquid, said liquid is introduced into the system to be within the prior Kisora sinus, there is no or substantially gas into the air-dong, claim The system according to 6 or 9. The system according to any one of claims 1 to 13, wherein the system further comprises means for releasing the low pressure or suction force of the liquid. The system
Means for introducing a liquid into the cavity and / or means for extruding excess gas and / or liquid.
The system according to any one of claims 1 to 14, further comprising. The system
c) A means for reducing the cavity volume from its initial volume, wherein the initial volume is the volume of the cavity when the holding device is inserted into the cup implant to a set position. ,
d) Means for maintaining the reduced cavity volume and
The system according to any one of claims 1 to 15, further comprising. The cover assembly
At least one elastic and elastic coupled to the cover assembly so that there is a natural urgency of the elastic and elastically deformable region to return to its unstressed state when elastically deformed in a stressed state. Deformable area,
Further prepare,
The system according to any one of claims 1 to 16. 17. The system of claim 17, wherein the elastic and elastically deformable region is, or is coupled with, a portion of the proximal surface of the cover assembly. 17. The system of claim 17 or 18, wherein the elastic and elastically deformable region is or is coupled to a portion of the distal surface of the cover assembly. The system according to any one of claims 17 to 19, wherein the elastic and elastically deformable region is formed integrally with the cover assembly. The system according to any one of claims 17 to 20, wherein the elastic and elastically deformable region is formed from a portion of a material extending from the cover assembly. 21. The system of claim 21, wherein said portion of the material extending from the cover assembly comprises a material that is different from each surface of the cover assembly. 21. The system of claim 21, wherein said portion of the material is an extension of the material forming each surface of the cover assembly. The system of any one of claims 21-23, wherein said portion of the material extending from the cover assembly comprises at least one fin. 24. The system of claim 24, wherein the at least one fin comprises a plurality of fins, and two or more of the plurality of fins have substantially the same dimensions. The system according to claim 24 or 25, wherein the at least one fin comprises a plurality of fins, and two or more of the plurality of fins have different dimensions. The system according to any one of claims 17 to 26, wherein the elastic and elastically deformable region comprises one or more springs, one or more washers, or a combination of springs and washers. The cover assembly is configured to reach a stopper before loss of elastic deformation when at least a portion of the elastic and elastically deformable region is subjected to force, and the stopper forms a platform. The cover assembly so that the elastic and elastically deformable region can efficiently transmit force to the elastic and elastically deformable region and the entire body of the cover assembly. The system according to any one of claims 17 to 27, which effectively forms a non-moving unit together with said body. The stopper forming a platform with which the elastic and elastically deformable region abuts when stressed is in a non-stressed state due to plastic deformation of the part of the elastic and elastically deformable region that abuts with the platform. 28. The system of claim 28, which is appropriately separated from the elastic and elastically deformable region so as to abut the platform before losing its urgency to. Any of claims 17-29, wherein the appropriate pressure applied to the fitting device allows at least a portion of the elastic and elastically deformable region to elastically deform towards the distal surface of the cover assembly. The system described in one paragraph. The cover assembly is configured so that at least a portion of the elastic and elastically deformable region can reach the stopper when stressed, the stopper forming a platform, thereby the elastic and elastic. The non-moving unit is effective with the body of the cover assembly so that the deformable region can efficiently transmit force to the elastic and elastically deformable region and the entire body of the cover assembly. 30. The system of claim 30, wherein the stopper prevents further elastic deformation of the portion of the elastic and elastically deformable region. The system of any one of claims 1-31, wherein the cover assembly comprises a first hole that passes through it from the proximal surface and extends through it to the distal surface. A claim that the cover assembly further comprises a second hole in the distal surface beyond the seal, the second hole extending into the cover assembly but not penetrating the proximal surface. Item 1. The system according to any one of Items 1 to 32. The cover assembly comprises a plurality of parts that are fitted to form the cover assembly, and the plurality of parts
A first component comprising at least the proximal surface and optionally the distal surface.
A second component optionally having the distal surface,
With a sticker
Means for locking the seal to the first and / or second component, and
To prepare
The system according to any one of claims 1-3.

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